Telmisartan vs. Perindopril in Mild-Moderate Alzheimer's Disease Patients

NCT02085265 | Terminated Phase 2

• 1 other identifier: 148-2013
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 10

Brief Summary

To conduct a proof of concept study in patients with mild to moderate Alzheimer's Disease in order to determine if there is less global brain atrophy over one year, as measured by ventricular enlargement as a primary outcome measure, when patients are randomized to treatment with an angiotensin receptor blocker (ARB) compared to an angiotensin converting enzyme inhibitor (ACEI).

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; Perindopril; Telmisartan; Brain atrophy

Outcome Measures

Primary Outcomes (5)

• Ventricular enlargement

  Change in ventricular size, on 3D T1 MR imaging, after 12 months of treatment

  12 months

• Safety - Blood pressure

  Change in blood pressure (BP) measurements after 12 months of treatment.

  12 months

• Safety - Vital signs

  Change in vital sign (heart rate, pulse) measurements after 12 months of treatment.

  12 months

• Safety - Electrolytes

  Change in electrolyte measurements (Na, K) after 12 months of treatment.

  12 months

• Safety - Adverse Events

  Adverse events and serious adverse events over 12 months of treatment.

  12 months

Secondary Outcomes (3)

• Hippocampal volume

  12 months

• Grey/White matter volume

  12 months

• Cognitive and functional measures

  6 and 12 months

Other Outcomes (5)

• Neuropsychiatric Measures

  6 & 12 months

• Treatment responsiveness of Diffusion Tensor Imaging (DTI)

  12 months

• Treatment responsiveness of resting state functional MRI (rsfMRI)

  12 months

Study Arms (2)

Telmisartan

EXPERIMENTAL

Telmisartan 40 mg or 80 mg/day (depending on age and tolerability)

Drug: Telmisartan

Perindopril

ACTIVE COMPARATOR

Perindopril 2 mg, 4 mg or 8 mg/day (depending on kidney function and tolerability)

Drug: Perindopril

Interventions

Perindopril DRUG

Perindopril 2 mg, 4 mg or 8 mg/day (depending on kidney function and tolerability)

Also known as: Coversyl

Perindopril

Telmisartan DRUG

Telmisartan 40 mg or 80 mg/day (depending on age and tolerability)

Also known as: Micardis

Telmisartan

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age 50 years or older
• Standardized Mini Mental State Examination (SMMSE) score of 16-27 at screening visit
• Sufficient hearing and vision to participate in testing as per investigator's judgement
• Sufficient fluency in English to understand instructions and to be able to complete SMMSE
• A study partner who in the opinion of the study investigator has regular interaction with the participant, can be present for study visits, can provide a collateral history and can ensure compliance with study procedures
• HbA1C \<8.5%. Patients with stable type II diabetes are eligible for the study if there have been no severe hypoglycemic events requiring third party intervention (e.g. emergency department visit) for 6 months prior to randomization
• Patients on cholinesterase inhibitors or memantine, medications for vascular risk factors (e.g., hypertension, cholesterol, diabetes), or on psychotropic medications must be on a stable dose for 30 days prior to randomization.
• Intolerance, or any contraindications, to study medications
• Average SBP \<110mmHg or average DBP \<60 mmHg during screening
• Familial autosomal dominant form of Alzheimer's disease
• Creatinine clearance less than or equal to 30ml/min
• Serum potassium \> 5.5 mEq/L
• ALT 3x \> the upper limit of normal (ULN)
• History of angioedema
• Co-morbid acute or chronic conditions (including type I diabetes mellitus, other neurological conditions such as Parkinson's disease, psychiatric disorders, and severe or unstable medical conditions) that could confound assessments or would, in the judgment of the investigator, make the subject inappropriate for entry into this study

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Alzheimer's Drug Discovery Foundation: collaborator
• Weston Brain Institute: collaborator

Study Sites (10)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

University of Lethbridge

Lethbridge, Alberta, T1K 6T5, Canada

Location

UBC Hospital

Vancouver, British Columbia, V6T 2B5, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Parkwood Institute

London, Ontario, N6C 4R3, Canada

Location

Centre for Memory and Aging

Toronto, Ontario, M4G 3E8, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Baycrest Health Sciences

Toronto, Ontario, M6A 2E1, Canada

Location

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Perindopril; Telmisartan

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles

Study Officials

• Sandra Black, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Krista Lanctot, PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: March 12, 2014
• Study Start: March 1, 2014
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

CA (10)